study to compare an oral weekly islatravir/lenacapavir regimen with standard of care in virologically suppressed people with hiv-1

Conditions: HIV-1-Infection

Summary: the goal of this clinical study is to learn more about the safety and efficacy of switching to a once weekly tablet of islatravir/lenacapavir (isl/len) regimen versus continuing standard of care treatment in people with human immunodeficiency virus (pwh) who are virologically suppressed (hiv-1 rna levels \< 50 copies/ml) on a stable standard of care regimen for ≥ 6 months prior to screening. the standard of care includes 2 or 3 medicines, antiretroviral agents (arvs). the primary objective of the study is to evaluate the efficacy of switching to oral weekly isl/len tablet regimen versus continuing standard of care in virologically suppressed pwh at week 48.


Eligibility criteria:
key inclusion criteria: * hiv-1 rna \< 50 copies/ml for ≥ 6 months before screening, as documented by: 1. one hiv-1 rna \< 50 copies/ml immediately preceding the 24 weeks period prior to screening. 2. within 24 weeks prior to screening, if hiv-1 rna results are available, all levels must be \< 50 copies/ml. 3. during the 6 to 12 months period prior to screening, transient detectable viremia ≥ 50 copies/ml is acceptable ("blip") as long as it is not confirmed on 2 consecutive visits. * plasma hiv-1 rna levels \< 50 copies/ml at screening. * are receiving guideline-recommended standard of care treatment such as international antiviral society (ias), department of health and human services (dhhs), european aids clinical society (eacs) consisting of 2 or 3 arvs for ≥ 6 months prior to screening and willing to continue until day 1. individuals in treatment group 2 must also be willing to continue their standard of care through at least week 96. * individuals assigned female at birth and of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception. key exclusion criteria: * prior virologic failure. * prior use of, or exposure to, isl or len. * active, serious infections requiring parenteral therapy within 30 days before randomization. * active tuberculosis infection. * acute hepatitis within 30 days before randomization. * hepatitis b virus (hbv) infection, as determined below at the screening visit: 1. positive hbv surface antigen or 2. positive hbv core antibody and negative hbv surface antibody. note: individuals found to be susceptible to hbv infection (eg negative hepatitis b surface antibody at the screening visit, regardless of prior hbv vaccination history) should be recommended to receive hbv vaccination. * active hepatitis c virus (hcv) coinfection, defined as detectable hcv rna. note: individuals with prior/inactive hcv infection (defined as undetectable hcv rna) may be enrolled. * any of the following laboratory values at screening: 1. creatinine clearance (clcr) ≤ 30 ml/min according to the cockcroft-gault formula 2. alanine aminotransferase (alt) \> 5 x upper limit of normal (uln) 3. direct bilirubin \> 1.5 x uln 4. platelets \< 50,000/μl 5. hemoglobin \< 8.0 g/dl note: other protocol defined inclusion/exclusion criteria may apply.